21st Century Cures Act Now Law

On Dec. 13, President Barack Obama signed H.R. 34, the
21st Century Cures Act (Cures), into law. The expansive bill, which passed both
the U.S. House and Senate with overwhelming bipartisan support, aims to speed
the discovery and development of new therapies to patients, and also seeks to
address challenges in health care delivery. The final legislation was the
product of more than two years of thoughtful, diligent, and bipartisan
discussions in both the House and Senate, and a tremendous outreach and
educational effort on the part of the medical research and patient advocacy
communities.

The American Association for Cancer Research (AACR) has been
monitoring Cures and meeting with key members of Congress about this landmark
legislation from the very beginning. Our top priority in the legislation was
additional funding for the National Institutes of Health (NIH) and Food and
Drug Administration (FDA). The final legislation provides $4.8 billion for the
three signature Obama administration research programs – Vice President Joe
Biden’s National Cancer Moonshot Initiative, renamed the “Beau Biden Cancer
Moonshot,” the BRAIN Initiative, and the Precision Medicine Initiative.
Specifically, the bill includes $1.8 billion over seven years in supplemental
funding for cancer research, with $300 million available for the current fiscal
year. This infusion of funds will enable the National Cancer Institute to fund
Moonshot projects and initiatives.

It is vitally important that NIH also receive robust,
sustained, and predictable funding increases through the regular appropriations
process. Therefore, the funding that is provided for the specific initiatives
that are included in 21st Century Cures must supplement, not supplant, annual
appropriations to the NIH, according to the AACR.

Beyond funding, the Cures bill includes other significant
provisions that will have an impact on cancer research and drug development.
These include:

A new
program to support young investigators at the NIH;

Language
to encourage health disparities research and greater inclusion of
underrepresented populations in clinical trials;

The
establishment of an Oncology Center of Excellence at the FDA;

Establishment
of a process for the qualification of biomarkers and other drug
development tools;

The
inclusion of patient experience data in drug development;

The
reauthorization of a priority review voucher program to encourage
development of new therapies for pediatric diseases, including cancer;
and,

An
expansion of hiring authority at the FDA to assist the agency in recruiting
and retaining staff members with the required scientific expertise.

Immediately after Cures passed in the Senate, the White
House issued a statement noting that “we are now one step closer to
ending cancer as we know it.” This echoed the statement released by the White House following
passage of the bill in the House, which noted that this “critically important
legislation responds to the vice president’s call for a moonshot in cancer
research by investing $1.8 billion in new resources to transform cancer
research and accelerate discoveries.”

In addition to meeting with congressional offices to build
support for 21st Century Cures, the AACR sent a letter to
members of Congress expressing its support for the bill, specifically
supporting funding for the Beau Biden Cancer Moonshot. The AACR also released
press statements following House and Senate passage of the bill, as well as on the day
President Obama signed the bill into law.

Looking ahead, the AACR stands ready to work with both sides
of the aisle on behalf of cancer patients and survivors everywhere. We’re
grateful to President Obama and Vice President Biden for their dedication in
the fight against cancer throughout this past year, culminating in Tuesday’s
signing of the new law, and we call on President-Elect Trump to exhibit the same
kind of support over the next four years.

U.S. House of Representatives Welcomes Over 50 New Members

Jan. 3, 2017, marks the start of the first session of the 115th Congress with Republicans maintaining control of both the House and the Senate. The U.S. House of Representatives welcomes over 50 new members who join the returning members. Of the new members, three of the Republicans are from districts that had been represented by a Democrat in the previous Congress, while seven Democratic members come from districts that had been represented by a Republican.

Several incoming members have strong ties to and support for the cancer community. They include John Faso (R-NY), whose spouse is a cancer survivor, Donald McEachin (D-VA) and Jamie Raskin (D-MD), who are both cancer survivors, and Dwight Evans (D-PA) who served on the board of directors of the Fox Chase Cancer Center, among others. Over the next few weeks, the AACR Office of Science Policy and Government Affairs plans to meet with all incoming members to introduce them to the AACR and discuss ways in which the new Congress can support cancer research, patients, and survivors.

U.S. Senate Adds Seven New Members, Readies for Busy Session

The 115th Congress has seven new senators, including five Democrats and two Republicans. Many of incoming senators have a strong record of support for the National Institutes of Health (NIH), including Tammy Duckworth (D-IL), Todd Young (R-IN), and Chris Van Hollen (D-MD), who all voted in favor of the 21st Century Cures Act at the end of 2016 during their time as members of the House of Representatives.

Van Hollen, in particular, who won the seat vacated by Senator Barbara Mikulski, has been a strong supporter of NIH. He was the Representative of Maryland's 8th Congressional District, which includes the NIH headquarters and intramural research campus in Bethesda, MD. He was the co-chair of the Childhood Cancer Caucus and served as the Ranking Member on the powerful House Budget Committee during the last Congress.

The first order of business for the Senate will be confirming President-Elect Donald Trump's nominees, including Representative Tom Price for Secretary of Health and Human Services, which oversees the National Institutes of Health and the Food and Drug Administration.

Save the Date Sept. 13-14: Rally for Medical Research Hill Day 2017

The fifth annual Rally for Medical Research Hill Day will be
held Sept. 14, 2017, in Washington, D.C., with a reception on the evening
prior. Stay up-to-date on registration and hotel information by visiting the
Rally website, Facebook, and Twitter pages.